NCT07365267 Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
| NCT ID | NCT07365267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2026-01-15 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
Eligibility Criteria
Inclusion Criteria: * Female breast cancer patients aged 18 to 70 years. * Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines. * Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction. * ECOG performance status of 0-1. * Voluntary participation in the study and signing of the written informed consent form. Exclusion Criteria: * Age \>70 years. * Metastatic breast cancer (Stage IV) at initial diagnosis. * Multicentric, extensive, diffuse lesions, or inflammatory breast cancer. * Tumor involvement of the nipple-areolar complex. * Breast cancer during pregnancy. * History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer. * Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery. * Patients deemed unsuitable for participation by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07365267 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07365267 currently recruiting?
Yes, NCT07365267 is actively recruiting participants. Contact the research team at vascularzhang@163.com for enrollment information.
Where is the NCT07365267 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07365267 clinical trial?
NCT07365267 is sponsored by Xijing Hospital. The trial plans to enroll 25 participants.
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